MAUDE Adverse Event Report: COOK ENDOSCOPY HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC; KNQ, DILATOR, ESOPHAGEAL

Catalog Number HBD-W-10-11-12

Device Problems Hole In Material (1293); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturer exemption number: e2015051.This mdr report is part of the (b)(4) pilot program.Concomitant medical products: cook qid-1 inflation device,.035 wire guide (unknown type).For the one (1) reported event, the device was returned to cook endoscopy.Our laboratory evaluation of the product said to be involved confirmed the report.During a functional test a 60 cc syringe and inflation handle were attached to the inflation port on the balloon.When filling the balloon up with water, a leak was observed coming out of the proximal end of the balloon at the balloon joint.There appeared to be some damage and kinking at the proximal balloon joint.No portion of the balloon material was missing.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.A definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The additional information provided indicated the balloon did not receive lubrication or negative pressure prior to advancement through the endoscope.This is the most likely cause for the reported observation.The instructions for use direct the user to "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." this activity will aid in endoscopic advancement and balloon preservation.The instructions for use direct the user: "to facilitate passage through the endoscope, apply negative pressure to the device".The application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.Negative pressure will also aid in balloon preservation and optimize balloon performance.Damage to the balloon material can occur if the balloon is inflated prior to advancement through the endoscope or if the balloon is inflated while partially or fully inside the accessory channel of the endoscope.The instructions for use contain the following precaution: ¿do not pre-inflate the balloon.¿ the instructions for use direct the user to ensure the balloon is completely visualized and positioned before inflation.The instructions for use contain the following warning: ¿during dilation, do not inflate balloon beyond the maximum indicated inflation pressure.¿ over inflation can cause damage to the balloon dilator.Another possible contributing factor is using a compromised inflation device to inflate the balloon.If the pressure reading of the inflation device is inaccurate, this could contribute to over inflation, possibly resulting in damage to the balloon material.Prior to distribution, all hercules 3 stage wireguided balloon esophageal-pyloric-colonic are subjected to a visual examination to ensure device integrity.A review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.Based on the information provided, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

This report summarizes one (1) malfunction event.A review of this event indicated that during a dilation of the duodenal papilla, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The physician put the hercules 3 stage wireguided balloon esophageal-pyloric-colonic to the desired position through [with the] wire guide.The balloon was ruptured while halfway inflated.The one (1) event involved a patient with no consequences.

• Brand Name: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Type of Device: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 5808291
• MDR Text Key: 49980526
• Report Number: 1037905-2016-00212
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002517950
• UDI-Public: (01)00827002517950(17)181006(10)W3633215
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HBD-W-10-11-12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/03/2016
• Device Age: 7 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS-JF-260V ENDOSCOPE
• Patient Age: 85 YR
• Patient Weight: 63